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ZOMIG 5MG NASAL SPRAY

Active substance: ZOLMITRIPTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zomig 5 mg Nasal Spray
zolmitriptan
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
P034387

In this leaflet:
1. What Zomig Nasal is and what it is used for
2. Before you use Zomig Nasal
3. How to use Zomig Nasal
4. Possible side effects
5. How to store Zomig Nasal

2. Before you use Zomig Nasal
Do not use Zomig Nasal if:
• You are allergic (hypersensitive) to zolmitriptan or
any of the other ingredients of this medicine (see
Section 6: Further information).
• You have high blood pressure.
• You have ever had heart problems, including a
heart attack, angina (chest pain caused by exercise
or effort), Prinzmetal’s angina (chest pain which
happens at rest) or have experienced heart related
symptoms such as shortness of breath or pressure
over the chest.
• You have had a stroke or short-lasting symptoms
similar to stroke (transient ischaemic attack or TIA).
• You are at the same time taking some other
medicines for migraine (e.g. ergotamine or
ergot-type medicines like dihydroergotamine
and methysergide) or other triptan medicines
for migraine. See section below: ‘Taking other
medicines’ for further information.
Do not use Zomig Nasal if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before using Zomig Nasal.

• Migraine symptoms may be caused by swollen
blood vessels in the head. Zomig Nasal is thought
to reduce the widening of these blood vessels. This
helps to take away the headache and other symptoms
of a migraine attack, such as feeling or being sick
(nausea or vomiting) and being sensitive to light
and sound.

Take special care with Zomig Nasal
Before you use Zomig Nasal, tell your doctor if:
• You are at risk of getting ischaemic heart disease
(poor blood flow in the arteries of the heart).
Your risk is greater if you smoke, have high blood
pressure, high levels of cholesterol, diabetes or if
anyone in your family has ischaemic heart disease.
• You have been told that you have Wolff-ParkinsonWhite Syndrome (a type of abnormal heart beat).
• You have ever had liver problems.
• You have headaches which are not like your usual
migraine headache.
• You are taking any medicine for treatment of
depression (see section below: ‘Taking other
medicines’ for further information).

• Zomig Nasal works only when a migraine attack has
started. It will not stop you from getting an attack.

If you go into hospital tell the medical staff you are
taking Zomig Nasal.

6. Further information
1. What Zomig Nasal is and what it is used for
Zomig Nasal contains zolmitriptan and belongs to a
group of medicines called triptans.
Zomig Nasal is used to treat migraine headache.

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Zomig Nasal is not recommended for people aged
under 18 years or over 65.
As with other migraine treatments, using too much
Zomig Nasal can cause daily headaches or can make
your migraine headaches worse. Ask your doctor if you
think that this is the case for you. You may need to stop
using Zomig Nasal to correct the problem.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes herbal medicines and medicines you buy
without prescription.
In particular, tell your doctor if you are taking any of the
following medicines:
Medicines for migraine:
• If you take a triptan other than Zomig Nasal (such
as sumatriptan or naratriptan) leave 24 hours
before using Zomig Nasal.
• After using Zomig Nasal leave 24 hours before
taking another triptan.
• If you take medicines containing ergotamine or
ergot-type medicines (such as dihydroergotamine
or methysergide), leave 24 hours before using
Zomig Nasal.
• After using Zomig Nasal leave 6 hours before taking
ergotamine or ergot-type medicines.
Medicines for depression:
• Mono-Amine Oxidase Inhibitors, also known as MAOIs
(such as moclobemide).
• SSRIs (selective serotonin reuptake inhibitors) such
as fluoxetine, paroxetine, fluvoxamine or sertraline.
• SNRIs (serotonin norepinephrine reuptake inhibitors)
such as venlafaxine or duloxetine.
Other medicines:
• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).
You should not take the herbal remedy St. John’s wort
(Hypericum perforatum) at the same time as this
medicine. If you already take a St. John’s wort
preparation, stop taking the St. John’s wort and
mention this to your doctor at your next visit.

Using Zomig Nasal with food and drink
You can take Zomig Nasal with or without food. It does
not affect the way that Zomig Nasal works.
Pregnancy and breast-feeding
• It is not known if using Zomig Nasal during
pregnancy is harmful. Before using Zomig Nasal,
tell your doctor if you are pregnant or trying to
become pregnant.
• Before using Zomig Nasal, tell your doctor if you
are breast-feeding.
Driving and using machines
• During a migraine attack your reactions may be
slower than usual. Bear this in mind when you drive
or use any tools or machines.
• Zomig Nasal is unlikely to affect driving or using tools
or machines. However, it is best to wait to see how
Zomig Nasal affects you before you try these
activities.
3. How to use Zomig Nasal
Zomig Nasal comes in a ready-to-use spray unit. Each
unit contains 5 mg of zolmitriptan. Each unit is for
single use and gives only one dose.
Always use Zomig Nasal exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
You can use Zomig Nasal as soon as a migraine
headache starts. You can also use it once an attack is
underway.
• The usual dose is one spray (5 mg) in one nostril. It
does not matter which nostril you use.
• You can use another spray if the migraine is still
present after two hours or if it returns within 24 hours.
If the nasal spray did not give you enough help with your
migraine, tell your doctor. Your doctor may change your
treatment.
Do not use more than the dose prescribed for you.
• Do not use more than two spray doses in one day.
The maximum daily dose is 10 mg.
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How to use Zomig Nasal
Please read these instructions before using Zomig Nasal.
A. The Protective Cover:
A
• This covers the nozzle to
protect it.
• Remove it before you use the
nasal spray.
B
B. The Nozzle:
• You put this part into your nose.
C
• The medicine comes out of a tiny hole C
in the top.
C. The Finger-grip:
• You hold this part when you use the
spray.
D
D. The Plunger:
• You press this part once you have put the nozzle
comfortably into your nose.
• The spray contains only one dose and works
only once.
Do not press the plunger until you have put the nozzle
in your nostril or you will lose the dose.
1 • Blow your nose gently
1
before use.
• Remove the protective cover.
2 • Hold the nasal spray gently
with your fingers and thumb as
2
shown in picture 2.
Do not press the plunger yet!
3 • Block one nostril by pressing a
finger on the side of your nose as
shown in picture 3.
• Put the nozzle of the nasal spray
into the other nostril as far as 3
feels comfortable.
• Tilt your head back slightly
and close your mouth as
shown in picture 3.
• Breathe in gently through
your nose and at the same time press the plunger
firmly with your thumb. The plunger may feel
stiff and you may hear it click.
• Keep your head slightly tilted back. Remove the
nozzle from your nose.
• Breathe gently through your mouth for
5-10 seconds. You may feel liquid inside your
nose. This does not mean that the dose is being
lost or that the spray has failed. This is normal
and will soon pass.

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If you use more Zomig Nasal than you should
If you have taken more Zomig Nasal than prescribed
by your doctor, tell your doctor or go to the nearest
hospital straight away. Take the Zomig Nasal medicine
with you.
4. Possible side effects
Like all medicines, Zomig Nasal can cause side effects,
although not everybody gets them. Some of the symptoms
below could be part of the migraine attack itself.
Stop using Zomig Nasal and contact your doctor
straight away if you notice any of the following:
Rare (affects less than 1 in 1,000 people)
• Allergic reactions including itchy rash (urticaria) and
swelling of the face, lips, mouth, tongue and throat.
Very rare (affects less than 1 in 10,000 people)
• Angina (pain in the chest, often brought on by
exercise), heart attack or spasm of the blood vessels
of the heart. The signs include chest pain and
shortness of breath.
• Spasm of the blood vessels of the gut, which can
cause damage to your gut. The signs include
stomach pain or bloody diarrhoea.
• Bleeding in the brain (cerebral bleeding) or stroke.
Other possible side effects:
Very common (affects more than 1 in 10 people):
This is usually mild and goes away after a short time.
• Taste disturbance.
Common (affects less than 1 in 10 people):
These are usually mild and go away after a short time.
• Abnormal sensations such as tingling in your fingers
and toes or skin that is sensitive to touch.
• Feeling sleepy, dizzy or warm.
• Headache.
• Uneven heart beat.
• Nose bleed, irritation in the nose or the nose being
more sensitive than usual.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain or pressure in the throat,
neck, arms and legs or chest.
• Problems swallowing.

Uncommon (affects less than 1 in 100 people):
• Very fast heart beat.
• Slightly higher blood pressure.
• An increase in the amount of water you pass (urine)
or in how often you need to pass water.
Do not be concerned by this list of possible side effects.
You may not get any of them. If any of the side effects
get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. How to store Zomig Nasal
• Keep out of the reach and sight of children.
• Keep your medicine in the container it came in.
• Do not use Zomig Nasal after the expiry date stated
on the carton. The expiry date refers to the last day
of that month.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further information
What Zomig 5 mg Nasal Spray contains
The active ingredient is zolmitriptan. Zomig 5 mg Nasal
Spray contains 5 mg zolmitriptan in each dose. The
other ingredients are: citric acid, disodium phosphate
and purified water.
What Zomig 5 mg Nasal Spray looks like and
contents of the pack
• Zomig 5 mg Nasal Spray is a pre-assembled device.
• Zomig 5 mg Nasal Spray comes in pack sizes of
6 single use nasal spray units.
• Each nasal spray unit is ready-to-use and gives
only one dose.
Zomig may also be available as film-coated tablets 2.5 mg
and 5 mg and orodispersible tablets 2.5 mg and 5 mg.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zomig 5 mg Nasal Spray
is held by AstraZeneca UK Limited,
600 Capability Green, Luton, LU1 3LU, UK.
Zomig 5 mg Nasal Spray is manufactured by
AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

To listen to or request a copy of
this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Zomig 5 mg

Nasal Spray
Reference number 17901/0095
This is a service provided by the
Royal National Institute of
Blind People.
Leaflet updated: June 2012
© AstraZeneca 2012
Zomig is a trade mark of the AstraZeneca group of companies.
You can also get support and information about migraine
from Migraine Action Association (UK),
Unit 6, Oakley Hay Lodge Business Park,
Great Folds Road, Great Oakley, Northants NN18 9AS
CNS 12 0036

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07/08/2012 07:35

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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